This year's J.P. Morgan Healthcare conference in San Francisco took a sinister turn. When Genentech's Art Levinson took the stage, he pointed out that the DNA helix on the official meeting logo, splashed on every badge, had a left-handed spiral--something that doesn't occur in nature. Oops!

Kudos to Levinson on his powers of observation. But perhaps the meeting organizers were making a symbolic rather than a literal statement. It seems like biotech's corkscrew has been spinning endlessly into the ground over the past year, and the question at this year's meeting, the unofficial kickoff to the life science's Year of the Ox, is whether we're soon going to see change we can believe in.

Certainly at ground level the industry will see unavoidable change. Biotech companies will have to continue to do more with less, and that unfortunately means some companies will probably pursue more "Hail Mary" phase 2 programs that push compounds into pivotal trials before enough is really known about them. The upshot will be more risk pushed onto shareholders who probably don't appreciate the difference between a well-vetted phase 2 program and a quick "shot on goal." And that could in turn increase the perceived risk of drug development and further depress investment dollars, a vicious cycle in the making.

Not that this is unavoidable. Personally, I'd like to see venture capital investment more focused on developing platform technologies and less on leveraging the single-product opportunities that have been so popular over the last few years ...and that again leave shareholders with more risk that I think they typically appreciate.

But the real change may need to come from Big Pharma. These leaders, generally well funded and selling products that remain in demand even in recession, have been relatively safe havens of late. But while greater scale increases the efficiency of many things, it doesn't increase creativity nor, it appears, R&D productivity. The engine of their future success remains firmly rooted in the biotech industry, and they need to get the best out of it.

Doing that--and getting the most for their own shareholders in the process--calls for more risk-taking. Why on earth aren't big pharma companies buying up or licensing depressed biotech assets at a breakneck pace? It seems like the same guys who are afraid of a hostile bid or a risky acquisition will happily overpay for a company once an outside activist steps in and puts it "officially" up for sale. The same folks who'll fork over 14 times sales for a commercial product don't want to take a gamble on a phase 3 program, even when the risk-discounted value is through the roof. No one wants to be associated with the big investment that blows up in a clinical trial six months or a year later. Indeed, these are truisms of the industry, but only because current culture and promotion practices so faithfully punish risk-taking. Not surprising, then, if the world's largest pharma companies find their upper ranks swelled by the overly cautious.

So here's a wish for the New Year: Let's see Big Pharma grab the Ox by the horns and leverage a position of strength into something that can benefit the entire life sciences industry.

Elan has lately been making news for what it's not doing. First, it's not in talks to be acquired by Pfizer, according to CEO Kelly Martin. (Shortly after making this claim, however, the company brought on Citigroup to explore strategic options, including a sale or merger.) Second, Elan is not extending phase 3 trials of bapineuzumab, its Alzheimer's treatment. A Bloomberg News report indicated otherwise, which put more pressure on the company's already troubled stock and besieged management. Actually, a lot of clinical news this past month is more about what is going to happen soon rather than what is happening now. A number of key study results are expected over the next few weeks--Intermune's pulmonary fibrosis drug and Synta's melanoma drug, for instance--and an absolute slew of data is expected around mid-year.
-KT

DIA - Comparability ChallengesRegulatory and Scientific Issues in the Assessment of Biopharmaceuticals. Recognize the information needed to assure comparability of product made by current and proposed new manufacturing processes; and review the previous approaches and the FDA perspective of such evaluations.

Aptuit is a pharmaceutical services company focused on streamlining and supporting the drug development process for biotech and pharma innovators. Aptuit has been engineering a better drug development process by amassing a staff of consummate professionals, breakthrough technologies, facilities and new ideas to offer its clients seamless and globally integrated services.

Nobody can accuse the Obama Administration of wasting time when it comes to making political appointments. His cabinet was filled in record time, and it has become reasonable to think that the role of FDA commissioner--often a political afterthought that in the case of former president George W. Bush remained vacant for over two years--will be quickly filled. Indeed, an appointment may already have been made by the time you read this, but as of this writing, media outlets are reporting a very short list and predicting an imminent decision. In Vivo Blog suggests it's down to two names: Baltimore Commissioner of Health Joshua Sharfstein and Duke University researcher Robert Califf. Sharfstein is already working on the team for the Health and Human Services transition, which In Vivo suggests might give him an edge. What's truly remarkable, however, is that we probably won't have to wait long to find out. -KT

FDA Commissioner Update: Califf's Name Emerges, But Is Sharfstein the Pick? More...

Molecular Medicine Tri-Conference provides the breadth and depth of information critical to your organization's success. The 2009 event includes ELEVEN parallel tracks that provide compelling and in-depth insight into the future of molecular medicine. www.Tri-Conference.com.

11th Annual BIO CEO & Investor ConferenceDiscover companies that aren't on everybody's radar screen. See their leadership teams in action, learn first hand about the science on which their futures depend, and meet privately with company CEOs. No other investor conference features such high-level discussions between MDs, CSOs and industry analysts.

Belgium's Galapagos NV may be named for a place that moves at the slow pace of evolution, but the company has lately been advancing pretty briskly. A big deal with Merck on obesity/diabetes targets was closely followed by an expansion of an existing partnership with GlaxoSmithKline on anti-infectives. And the company recently scored a couple milestone payments under programs with Janssen and GlaxoSmithKline.

Meanwhile, on the less friendly side of the deal-making world, Exact Sciences is trying to fight back against a hostile bid from Sequenom. Given that the money-losing company only has six months of cash left, I'm not sure how wise it is to turn down a deal that represented a 68% premium to Exact's stock price at the time it was offered. But Exact's job is to maximize return to shareholders, and if they believe their patent portfolio or anything else can substantially sweeten the deal, more power to them. They have a good fit with Sequenom, so it's not clear to me there will be other offers in the wings.
-KT

CV Therapeutics, Inc.Vice President, Medical Affairs
The Vice President of Medical Affairs will be responsible for providing leadership to key functional areas within Medical Affairs (Sr. Medical Director and Medical Director(s) and members of the Professional Services team - Medical Information, Medical Science Liaisons).
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Illumina, Inc.VP, Array Biochemistry
This position directs the activities of a scientific group in the research and/or development of an organization's products, projects and programs. The position will be responsible for the development of platforms for Genotyping, Gene Expression, and/or Sequencing Systems.
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Covance Inc.Vice President & General Manager Translational Medicine
The Vice President of Translational Medicine in Drug Development is responsible for leading Covances strategy for the successful translation of non-human research to first in human clinical trials on behalf of our clients. In this role, you will be the key interface to opinion leaders, clinicians, scientists, and researchers who conduct analysis of potential drug targets that address a wide range of diseases.
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Pharm Country Career Fair
BioSpace is pleased to present the Pharm Country Career Fair on Monday, February 2, 2009 at the Bridgewater Marriott in Bridgewater, NJ.

Biotech Beach Career Fair
BioSpace is pleased to present the Biotech Beach Career Fair on Monday, February 23, 2009 at the San Diego Marriott La Jolla in La Jolla, CA.

Everyone these days know that money talk is mostly about how to hold onto it. And that thrift is ravaging through the life sciences sector in the form of an unprecedented IPO drought, a lack of secondaries, and slow M&A. Especially hard hit are those companies that rely on the capital budgets of hospitals--most particularly medical device makers. Hospitals get their capital budgets from a variety of sources. Many count on charitable contributions (uh-oh!); some even rely on investment gains (yikes!!). So it's a tough time to be trying to convince a hospital to invest in fancy new gadgets, which has led to soft sales and/or warnings from a broad swath of device companies...everyone from robotic surgery expert Intuitive Surgical to heart catheterization company Hansen Medical to diagnostic and imaging company Hologic. At the J.P. Morgan Healthcare conference, device behemoth Stryker said that over half of hospitals have frozen (or nearly frozen) capital spending altogether. Biotechs can take solace in the fact that pharmacy comes from a different budget, but this is a tough time to be introducing anything that even hints at unnecessary novelty.
-KT

Alladex: Drug Development - From Lab to Market This new set of rapid-learning tools has been developed to enable scientists and business people to learn the key points of drug development from laboratory to market rapidly, easily and cost effectively. The unique 1-Day Alladex Course (now in its fourth year) follows the development of a drug on film from laboratory to market interspersed with key points slides and discussion. www.alladex.com.

Haas Business of Healthcare Conference provides an interdisciplinary forum where cutting-edge information and innovative approaches to health care are shared. This year's Haas Business of Health Care Conference will be held on February 7, 2009 and will focus on the theme "the impact of integration". The event will feature an exciting lineup of keynotes and panel topics.

In the final days of the Bush Administration, FDA okayed guidelines allowing drug companies to distribute medical journal articles describing off-label use of drugs. This modest form of off-label promotion is a slippery slope, critics argue, that could lead to unsafe prescribing and give companies less incentive to do the rigorous studies necessary for label expansion. That's theoretically possible, I suppose, but I've never seen the wisdom to any policy based on denying people information. In any case, it will be an interesting test of the Obama Administration to see if this policy is allowed to stand. Congressional Democrats have generally been hostile to any formalization of off-label promotion -KT

Why choose Max Neeman International in India?Max Neeman International's M.D. and Ph.D. trained teams maintain the expertise to assist the pharmaceutical, biotech and device industries, in conducting complex clinical trials -- to 'Top 10' pharmaceutical firms, as well as small to midsize biotechnology and device companies.

2009 BIO Human Resources: Our 2009 conference theme is, HR Leading During Times of Change. We are broadening our focus to include global issues, organization and development challenges, strategic issues and best practices from fellow industry professionals. Request for Proposals due Friday, January 30, 2009.

Let the fibromyalgia wars begin! Forest Labs and Cypress Bioscience have gotten FDA's blessing to launch Savella. It will compete against Pfizer's Lyrica--which I've already seen getting more advertising air time--as well as Lilly's Cymbalta. With fibromyalgia being a disease of uncertain etiology and variable symptoms...and with some doctors doubting it even strictly exists outside the mind...companies are likely to count on ad dollars to embolden patients and drive revenue. Cypress is touting a superior label for Savella, which they say is approved to treat a broader array of symptoms than just the pain targeted by Lyrica and Cymbalta. -KT